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FDA 510(k)

Flexitouch System

K-Number: K170216 · 2017-05-26

ApplicantTactile Systems Technology, Inc. (Dba Tactile Medical)
Decision Date2017-05-26
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Flexitouch System is the device name listed in this FDA 510(k) record. The listed applicant is Tactile Systems Technology, Inc. (Dba Tactile Medical). It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K170216. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flexitouch System?

Flexitouch System is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Tactile Systems Technology, Inc. (Dba Tactile Medical). The 510(k) number is K170216.

When did Flexitouch System receive FDA 510(k) clearance?

Flexitouch System received FDA 510(k) clearance on 2017-05-26, under 510(k) number K170216.

Who is the listed applicant for Flexitouch System?

The FDA 510(k) record lists Tactile Systems Technology, Inc. (Dba Tactile Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flexitouch System?

The FDA product code for Flexitouch System is JOW.

Other records listing Tactile Systems Technology, Inc. (Dba Tactile Medical) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203178Flexitouch Plus SystemK153311Flexitouch System

Related Devices (Code: JOW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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